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New e-form for minor variations
Prescription medicines
Adrian Bootes, Felicity Jameson, Klara Koelmeyer, Karen Loft Medicines Regulation Division Therapeutic Goods Administration
3rd July 2017 - Sydney 5th July 2017 - Melbourne
New e-form for minor variations Prescription medicines Adrian - - PowerPoint PPT Presentation
New e-form for minor variations Prescription medicines Adrian - - PowerPoint PPT Presentation
New e-form for minor variations Prescription medicines Adrian Bootes, Felicity Jameson, Klara Koelmeyer, Karen Loft Medicines Regulation Division Therapeutic Goods Administration 3 rd July 2017 - Sydney 5 th July 2017 - Melbourne Minor
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Reducing regulatory burden
- Need for improvements to processes
- Staged approach to improve the processing of minor variations
- Number of Minor Variations received in 2016-2017 financial year
Category Number 9D(1) 122 Category 3 1345 MEC 458 SAR 1232 SRR 707 Total 3864
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New electronic form
First step for prescription medicines
One-stop shop
- Consolidating six paper forms into one electronic
portal
- Reduced time and effort in making minor
variations applications
- More efficient processing of requests
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Applicant/Client information
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Searching for your goods
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Searching for your goods
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Selecting your goods
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Selecting your goods
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Creating a variation
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Creating a variation (2)
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Easy selection of Variation Types
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Variation type <Formulation>
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Variation type <Pack size and Poison schedule>
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Known areas for development
- Current known warnings
– Manufacturer information
- Link between ARTG and manufacturer database (MIS) –
‘invisible’ sites – Missing PAR details in existing ARTG entries – Quantity Sufficient (QS) in formulation
- Value required (0 – QS)
- Any others please tell us
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Summary of changes and associated fees before you submit
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Submission number generated at point of submission
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Print Preview
(page 1)
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Print Preview
(page 2)
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Next steps
Guidance updated and published - printable version and e-book e-form launch - external stakeholders involved Ongoing improvements - new ‘notifications’ process
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More information Prescription Medicines Authorisation Branch Application Entry Team AET.application.entry.team@health.gov.au
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